TMF Strategy Lead & Compliance Senior Manager

Alfasigma; Lombardia; On-site; EUR 120,000 - 150,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Professional growth opportunities

Job summary

Alfasigma is seeking a Senior Manager, TMF Management to lead the Trial Master File governance and eTMF operations across the clinical portfolio. You will serve as the TMF SME, owning platform strategy and partner with Clinical Operations, Quality, IT, and CROs to ensure inspection readiness and compliant documentation.

The role emphasizes strategic leadership, team development, and ongoing process improvements within a highly regulated environment. Fluent English is required.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• Minimum 10 years of experience in clinical research.
• At least 5 years of direct TMF management experience.
• Strong knowledge of GCP/ICH/FDA regulations.
• Experience overseeing CROs and external vendors.
• Fluent English, written and spoken.

Responsibilities

• Serve as SME and business owner for TMF processes and Veeva eTMF platform.
• Define and implement strategic TMF roadmap and improvements.
• Lead and develop the TMF team fostering a quality culture.
• Oversee TMF quality management, metrics, CAPA, and inspections readiness.
• Ensure complete, accurate, contemporaneous study documentation.
• Collaborate with Quality, IT, and system stakeholders on validation and change control.
• Provide strategic oversight of TMF activities by CROs and vendors.
• Develop and deliver TMF training and best practices.
• Coordinate with cross-functional teams for consistent TMF execution.

Skills

TMF governance

eTMF oversight

team leadership

GCP/ICH compliance

stakeholder management

Education

Bachelor’s in Life Sciences

Master’s degree

Tools

Veeva eTMF

GxP compliant systems

Job description

Alfasigma is seeking a Senior Manager, TMF Management to lead the Trial Master File governance and eTMF operations across the clinical portfolio. You will serve as the TMF SME, owning platform strategy and partner with Clinical Operations, Quality, IT, and CROs to ensure inspection readiness and compliant documentation.

The role emphasizes strategic leadership, team development, and ongoing process improvements within a highly regulated environment. Fluent English is required.